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We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion.
Treatment groups would be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wait and watch (Group D) | No Intervention | Wait and watch for 1 month | |
| Mometasone spray (Group B) | Experimental | Standard dose of mometasone furoate nasal spray (one spray in each nostril once daily) for one month will be given |
|
| antibiotic + histaminic + oxymetazoline drops (Group A) | Experimental | This group will receive oral cefpodoxime (10 mg/kg/day in two divided dose for a week) plus oral histaminics and oxymetazoline drops. Standard dose of oral histaminics (levocetirizine, 1.25 mg for age below six years, 2.5 mg for older age) for a month plus oxymetazoline nasal drops (Nasivion 0.025%) for two weeks will be given |
|
| Oral steroid (Group C) | Experimental | Patients in this group will receive one mg/kg/day of oral prednisolone (Oral steroid) in two divided dose for a week followed by half mg/kg/day in two divided dose for next one week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone 50 Mcg/Inh Nasal Spray | Drug | One spray in each nostril once daily for one month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non B type tympanogram | one month |
| Measure | Description | Time Frame |
|---|---|---|
| cost of treatment | one month | |
| Adverse effects | one month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lumbini Medical College | Tānsen | Palpa | 32500 | Nepal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38088821 | Derived | Mulvaney CA, Galbraith K, Webster KE, Rana M, Connolly R, Tudor-Green B, Marom T, Daniel M, Venekamp RP, Schilder AG, MacKeith S. Topical and oral steroids for otitis media with effusion (OME) in children. Cochrane Database Syst Rev. 2023 Dec 13;12(12):CD015255. doi: 10.1002/14651858.CD015255.pub2. |
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As soon as the article is published online. Life-long
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| Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%) | Drug | Children in this group will be treated with antiboitics (syp cefpodoxime) at 10 mg/kg/day in two divided dose for a week, plus antihistamine and nasal decongestants. Oral levocetirizine (Syrup levocet 2.5 mg/5ml) 1.25 mg once daily for age up to six years, 2.5 mg once daily for elder children for a month, plus oxymetazoline (Nasivion) 0.025%, 4 drops twice daily for two weeks |
|
|
| Steroid Drug (prednisolone) | Drug | This group will be treated with steroid drugs. Oral prednisolone, 1 mg/kg body weight daily in two divided dose for 1 week followed by half mg/kg/day in two divided dose for next one week. |
|
| ID | Term |
|---|---|
| D010034 | Otitis Media with Effusion |
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| D000900 | Anti-Bacterial Agents |
| D006633 | Histamine Antagonists |
| C472067 | levocetirizine |
| D014663 | Nasal Decongestants |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018494 | Histamine Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D045505 | Physiological Effects of Drugs |
| D014662 | Vasoconstrictor Agents |
| D002317 | Cardiovascular Agents |
| D019141 | Respiratory System Agents |
| D011246 | Pregnadienetriols |
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